ERX1000 for Obesity

No longer recruiting at 1 trial location

Overseen By Teo Uysal

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: ERX Pharmaceuticals

Must not be taking: Weight loss drugs

Disqualifiers: Metabolic disorders, Liver disease, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new treatment called ERX1000 for individuals with obesity. Participants will receive either ERX1000 or a placebo to observe their body's reaction to the treatment. The trial seeks adults with a body mass index (BMI) between 30 and 39.9 who are otherwise in good health and not currently using any weight loss medications. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial protocol suggests that you may need to stop taking certain medications, especially those that could affect drug absorption, metabolism, or elimination, as well as any prescription or nonprescription medications, vitamins, or supplements, unless approved by the study doctor. It's best to discuss your specific medications with the study team to see if they are allowed.

Is there any evidence suggesting that ERX1000 is likely to be safe for humans?

Research has shown that ERX1000 is generally safe for people. In studies with healthy volunteers, most treatment-related side effects were mild. The most common were temporary stomach issues like nausea, which resolved on their own.

In tests with mice, ERX1000 reduced appetite and weight without causing major health problems, suggesting it could be a promising option for managing obesity. However, as this is an early trial phase, new data will be needed to confirm its safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard of care for obesity, which typically includes lifestyle modifications and medications targeting appetite suppression or fat absorption, ERX1000 presents a novel approach. ERX1000 is unique because it comes in the form of an oral suspension powder, offering flexible dosing options. Researchers are excited about ERX1000 because it could provide a more tailored treatment experience, potentially improving patient adherence and outcomes in managing obesity.

What evidence suggests that ERX1000 might be an effective treatment for obesity?

Research has shown that ERX1000, which participants in this trial may receive, could aid in treating obesity. In studies with diet-induced obese mice, ERX1000 improved sugar metabolism, lowered blood sugar levels, and increased insulin sensitivity. These results suggest that the treatment might help control blood sugar and enhance insulin use in humans, both crucial for managing obesity. Although information from human studies remains limited, these early findings offer hope for its effectiveness in addressing obesity. ^{1 2 3 6 7}

Who Is on the Research Team?

Irene Mirkin, MD

Principal Investigator

Labcorp Clinical Research Unit Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

The person is able to understand the information in the consent form and is willing to abide by the study restrictions.

The systolic blood pressure is between 90 and 140 mmHg.

The subject is determined to be in good health if there are no clinically significant findings from the subject's medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and/or Check-in.

Exclusion Criteria

Donation of blood from 8 weeks prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.

Consumption of alcohol from 72 hours prior to Check-in.

Use of tobacco- or nicotine-containing products (including nicotine and non-nicotine e-cigarettes, vaping, etc.) within 3 months prior to Check-in, or positive cotinine at Screening or Check-in.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive single oral doses of ERX1000 or placebo to assess safety and tolerability

4 weeks

Treatment Part B

Participants receive multiple oral doses of ERX1000 or placebo to assess safety and tolerability

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ERX1000
• Placebo

How Is the Trial Designed?

Group I: ERX1000 Experimental Treatment 1 Intervention

ERX1000 powder provided for preparation of a 4 mg/10 mL oral suspension and 8 mg/10 mL oral suspension Proposed dose level for Part A: 4 mg and 8 mg Proposed dose level for Part B: 4 and 8 mg. The dose administered will not exceed the highest dose administered in Part A.

Group II: Placebo Placebo Group 1 Intervention

Reference product: Magnesium hydroxide carbonate powder prepared in an oral suspension

Who Is Running the Clinical Trial?

ERX Pharmaceuticals

Lead Sponsor

Trials

1

Recruited

50+

Published Research Related to This Trial

In a review of 109 clinical studies with 1228 healthy volunteers, 19% reported adverse events during placebo administration, highlighting that even without active treatment, participants can experience side effects.

Adverse events were more common with repeated dosing (28%) and among elderly participants (26%), with headaches, drowsiness, and asthenia being the most frequently reported issues, indicating that placebo effects can significantly influence safety evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The placebo effect in healthy volunteers: influence of experimental conditions on the adverse events profile during phase I studies. Rosenzweig, P., Brohier, S., Zipfel, A.[2023]

Adverse events (AEs) are reported in 49.1% of trial participants in placebo groups, indicating that these events are quite common and not solely due to the natural progression of conditions.

The prevalence of AEs in placebo groups (6.51%) is higher than in untreated groups (4.25%), suggesting that the nocebo effect may play a significant role in the experience of AEs during clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid overview of systematic reviews of nocebo effects reported by patients taking placebos in clinical trials. Howick, J., Webster, R., Kirby, N., et al.[2022]

The Drug Adverse Reaction Database (DART) provides detailed information on 147 confirmed and 89 potential protein targets associated with adverse drug reactions (ADRs), which is crucial for understanding the mechanisms behind these reactions and aiding in drug discovery.

DART includes extensive data on 257 drugs and 1080 ligands, offering insights into their binding properties, physiological functions, and the specific adverse effects they may cause, making it a valuable resource for researchers and developers in pharmacology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Adverse Reaction Target Database (DART) : proteins related to adverse drug reactions. Ji, ZL., Han, LY., Yap, CW., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04890873

Study Details | NCT04890873 | ERX1000 Types of outcome measures include primary outcome measure and secondary outcome measure. ... A type of intervention model describing a clinical trial in which two ...

2. erxpharmaceuticals.com erxpharmaceuticals.com/research-development/erx-1000-for-obesity/

ERX-1000 for Obesity ERX-1000 improved glucose tolerance, reduced fasted and non-fasted plasma glucose concentrations, and improved insulin sensitivity in diet-induced obese mice.

3. withpower.com withpower.com/trial/phase-1-obesity-3-2021-11397

ERX1000 - Safety, Tolerability, Pharmacokinetic, and ... This Phase 1 medical study run by ERX Pharmaceuticals needs participants to evaluate whether ERX1000 and Placebo will have tolerable side effects & efficacy ...

4. biospace.com biospace.com/obesity-increases-covid-death-rate-10x-erx-pharmaceuticals-novel-approach-and-amp-research-could-be-gamechanger

Obesity Increases Covid Death Rate 10X, ERX ... ERX's research could greatly reduce the prevalence of obesity worldwide, saving millions of lives lost to illnesses caused by obesity and billions spent on ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11311839/

Molecular Mechanisms behind Obesity and Their Potential ... In a phase 2a trial with 342 obese patients receiving 400 mg or 1600 mg of velneperit (an NPY5R antagonist) once a day, dose-dependent efficacy was achieved, ...

6. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00059-7/fulltext

Pharmacotherapy of obesity: an update on the available ... We suggest a treatment algorithm taking into consideration patient's profile and medications efficacy and safety data. ... No adverse effects ...

7. synapse.patsnap.com synapse.patsnap.com/organization/ff3424222d32f7fe22b46c31891f43c6

ERX Pharmaceuticals Inc - Drug pipelines, Patents ... Most treatment-emergent adverse events (TEAEs) were mild and transient. The majority of the TEAEs were GI-related, with the most common being nausea and ...